NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) reported financial results for Q1 2024 and a corporate update. They dosed the first patient in the Phase 1 clinical trial of DA-1726 for obesity. Cash balance was $16.0 million, expected to fund operations until Q4 2024. They enrolled patients in the Phase 2a trial of DA-1241 for MASH and anticipate reporting top-line data in Q4 2024.
NeuroBo dosed the first patient in the Phase 1 clinical trial of DA-1726 for obesity, showing progress in clinical development. They anticipate presenting new pre-clinical data at the American Diabetes Association 84th Scientific Sessions, enhancing visibility. Additionally, the Phase 2a trial of DA-1241 for MASH is moving forward, with promising pre-clinical and clinical evidence supporting its potential as a safe and effective treatment.
Research and Development expenses significantly increased to $4.9 million in Q1 2024 compared to $0.6 million in Q1 2023, impacting profitability. Net loss for Q1 2024 was approximately $6.7 million, with a decrease in cash balance to $16.0 million. The company is exploring various financing alternatives to support operations beyond Q4 2024.
Insights
Reviewing NeuroBo Pharmaceuticals' financials reveals a substantial uptick in research and development (R&D) expenses, predominantly driven by heightened activity in their two lead programs, DA-1241 and DA-1726. The year-over-year increase is significant, indicating a strategic focus on advancing these assets through clinical trials, which is a customary phase of drug development requiring substantial investment.
With general and administrative expenses remaining relatively flat year-on-year, the company appears to be maintaining a controlled overhead while allocating resources towards its R&D endeavors. The critical figure here is the cash position of
New drug candidates DA-1726 and DA-1241 are at the forefront of NeuroBo's pipeline, targeting obesity and metabolic dysfunction-associated steatohepatitis (MASH), respectively. The advancement into clinical trials represents progress; however, for stakeholders, the path ahead remains laden with regulatory hurdles and clinical efficacy demonstrations.
The therapeutic arena of cardiometabolic diseases is highly competitive and the unique mechanisms of action for DA-1726, a dual oxyntomodulin (OXM) analog and DA-1241, a G-Protein-Coupled Receptor 119 (GPR119) agonist, warrant attention. Should these assets demonstrate clinical success and tolerability, they could present meaningful differentiation in the obesity and MASH treatment landscapes.
With top-line data readouts anticipated within the next year, these milestones will be pivotal in assessing the clinical and commercial viability of these assets. The market's response to these data releases will be indicative of the company's future trajectory.
Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024
Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024
Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024
Cash of
"During the first quarter and subsequently, we continued to diligently advance the clinical development of our two, next generation cardiometabolic assets, with promising therapeutic potential in the obesity and metabolic dysfunction-associated steatohepatitis (MASH) markets," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "This past month, we began dosing patients in our first-in-human, Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), in obesity. Based on pre-clinical evidence generated to date, we strongly believe that DA-1726 may offer a superior tolerability profile compared to currently available GLP-1 agonists, due to its unique ratio of GLP1R and glucagon receptors, reducing food intake while increasing energy expenditure, leading to improved patient outcomes. Looking ahead for DA-1726, we eagerly anticipate presenting new, compelling pre-clinical data at the American Diabetes Association 84th Scientific Sessions in June of this year. We anticipate reporting top-line data from the single ascending dose (SAD) Part 1 in the third quarter of this year and also expect to dose the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year, with the expectation for the top-line data from the MAD Part 2 in the first quarter of 2025."
Mr. Kim continued, "Additionally, just after quarter end, we fully enrolled Part 1 of the Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH. This milestone followed closely on the heels of the Safety Review Committee (SRC) approval, allowing the study to continue without modification, an early indication of the safety of DA-1241. Part 2 of this trial, in combination with sitagliptin, a DPP4 inhibitor, continues to enroll patients. Pre-clinical safety data, reported in January, showed promising results for DA-1241 for this combination therapy. Notably, two poster presentations, with new pre-clinical evidence on DA-1241 in combination with semaglutide (Segovia®), will be presented at the EASL Congress 2024, in June. Based on both pre-clinical and clinical evidence generated to date, we continue to believe that DA-1241 has the potential to be a safe and effective treatment for MASH and anticipate reporting top-line results in the fourth quarter of this year."
First Quarter 2024 and Subsequent Highlights
- April 2024: Dosed the first patient in the SAD Part 1 of its two-part Phase 1 clinical trial of DA-1726 for the treatment of obesity.
- April 2024: Completed enrollment of Part 1 of its two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.
- March 2024: Received SRC approval to continue the two-part Phase 2a trial of DA-1241 for the treatment of MASH without modification following a blinded safety review of the first six months of study conduct.
- March 2024: Announced the appointment of Marshall Woodworth as Chief Financial Officer, following his tenure as Acting Chief Financial Officer.
- February 2024: Received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of
Miami , inHialeah, FL , to proceed with the Phase 1 clinical trial of DA-1726 for the treatment of obesity. - February 2024: Announced that the FDA has cleared its Investigational New Drug (IND) application for the Phase 1 clinical trial of DA-1726 in obesity.
- January 2024: Reported positive pre-clinical safety data of DA-1241 in combination with sitagliptin, a DPP4 inhibitor. The pre-clinical results demonstrated that once daily oral administration in rats, of sitagliptin alone (180 mg/kg/day), DA-1241 alone (100 mg/kg/day), or sitagliptin in combination with DA-1241 (up to 180/100 mg/kg/day sitagliptin+DA-1241) for 13 weeks, was well tolerated with no adverse effects. Additionally, opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of MASH.
Anticipated Clinical Milestones
- DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024. Initiation of the multiple ascending dose (MAD) study Part 2 is expected in the third quarter of 2024 and the top-line data expected in the first quarter of 2025.
- DA-1241 in MASH: Full enrollment of the two-part Phase 2a clinical trial of DA-1241 in MASH is expected in the third quarter of 2024. Top-line results are expected to be available in the fourth quarter of 2024.
First Quarter Financial and Operating Results
- Research and Development (R&D) Expenses were approximately
$4.9 million $0.6 million $4.3 million $4.3 million $3.9 million $0.4 million - General and Administrative Expenses were approximately
$2.0 million $1.9 million $0.1 million $0.2 million $0.1 million - Other Income (Expense) was approximately
$0.2 million $0.1 million $0.2 million - Net Loss for the three months ended March 31, 2024, was approximately
$6.7 million $1.32 $2.6 million $0.51 - Cash was approximately
$16.0 million $22.4 million
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control.
For more information, please visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts:
NeuroBo Pharmaceuticals, Inc.
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
- Tables to Follow -
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(In thousands, except per share amounts) | ||||||
As of | ||||||
March 31, 2024 | December 31, 2023 | |||||
(Unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash | $ | 15,988 | $ | 22,435 | ||
Prepaid expenses and other current assets | 776 | 77 | ||||
Total current assets | 16,764 | 22,512 | ||||
Property and equipment, net | 47 | 46 | ||||
Right-of-use asset | 186 | 202 | ||||
Other assets | 21 | 21 | ||||
Total assets | $ | 17,018 | $ | 22,781 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable (including related party payable of | $ | 2,079 | $ | 821 | ||
Accrued liabilities (including related party payable of | 3,948 | 4,414 | ||||
Warrant liabilities | 728 | 658 | ||||
Lease liability, short-term | 70 | 67 | ||||
Total current liabilities | 6,825 | 5,960 | ||||
Lease liability, long-term | 117 | 136 | ||||
Total liabilities | 6,942 | 6,096 | ||||
Commitments and contingencies | ||||||
Stockholders' equity | ||||||
Preferred stock, | — | — | ||||
Common stock, | 5 | 5 | ||||
Additional paid–in capital | 125,050 | 124,945 | ||||
Accumulated deficit | (114,979) | (108,265) | ||||
Total stockholders' equity | 10,076 | 16,685 | ||||
Total liabilities and stockholders' equity | $ | 17,018 | $ | 22,781 | ||
NeuroBo Pharmaceuticals, Inc. | ||||||
Condensed Consolidated Statements of Operations | ||||||
(Unaudited - In thousands, except share and per share amounts) | ||||||
Three Months Ended March 31, | ||||||
2024 | 2023 | |||||
Operating expenses: | ||||||
Research and development | $ | 4,904 | $ | 637 | ||
General and administrative | 1,977 | 1,883 | ||||
Total operating expenses | 6,881 | 2,520 | ||||
Loss from operations | (6,881) | (2,520) | ||||
Other income (expense): | ||||||
Change in fair value of warrant liabilities | (70) | (84) | ||||
Interest income | 237 | — | ||||
Total other income | 167 | (84) | ||||
Loss before income taxes | (6,714) | (2,604) | ||||
Provision for income taxes | — | — | ||||
Net loss and comprehensive loss | (6,714) | (2,604) | ||||
Loss per share of common stock, basic and diluted | $ | (1.32) | $ | (0.51) | ||
Weighted average shares of common stock, basic and diluted | 5,089,408 | 5,059,003 | ||||
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SOURCE NeuroBo Pharmaceuticals, Inc.
FAQ
When is the top-line data from the single ascending dose Part 1 of DA-1726 expected?
The top-line data is expected in the third quarter of 2024.
What is the cash balance of NeuroBo as of March 31, 2024?
The cash balance was approximately $16.0 million as of March 31, 2024.
What is the stock symbol for NeuroBo Pharmaceuticals?
The stock symbol is NRBO.
What phase is the Phase 2a trial of DA-1241 for MASH currently in?
Part 2 of the Phase 2a trial for DA-1241 is currently underway.
